JPH11206849A - Drug drying body and drug packaging body - Google Patents

Abstract

PROBLEM TO BE SOLVED: To enable to keep the quality of effective components of a drug stably for a long period even if the drug is unstable against water or easily volatile, by sealing a drying agent into a bag made of a plastic film which is excellent in moisture permeability and gasproofness. SOLUTION: A drying body comprising a drying agent 20 sealed in a plastic film 10 together with a solid drug 40 such as a tablet is sealed into a sealing body 30. The plastic film 10 is selected by indices of: moisture permeating coefficient not lower than 1.0 g.mm/m<2> .24 hr (measurement: ASTMF 1249, 40 deg.C-90% R.H.); O2 permeability not higher than 5.0 ml(STP).mm/m<2> .24 hr.atm (measurement: ASTMD 3985, 23 deg.C-0% R.H.); and CO2 permeability not higher than 12.0 ml(STP).mm/m<2> .24 hr.atm (measurement: same as O2 permeability). As such a plastic film, for instance, nylon made film, polyvinyl chloride made film, polyethylene terephthalate made film, or the like, are preferable.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a dried product for medicine and a drug package containing the dried product.

[0002]

2. Description of the Related Art Conventionally, when a solid drug such as a tablet or various pharmaceuticals is sealed in a sealed body such as a bottle or a can, a desiccant such as silica gel is also sealed together for the purpose of preventing moisture. Thus, the desiccant is generally made of paper, cloth, or the like to avoid direct contact with the solid drug and to improve air permeability.
Those wrapped with a plastic film having holes are widely used.

[0003] However, in such a conventional desiccant, since the paper as the packaging material has high moisture permeability and high air permeability, for example, in the case of a solid drug unstable to moisture, the moisture in the drug is reduced. Although it is possible to quickly adsorb to the desiccant, if the drug contains a component that easily evaporates, it is necessary to prevent adsorption to the desiccant. There was a problem in maintaining stability.

[0004]

DISCLOSURE OF THE INVENTION The present invention has been made in view of the above-mentioned conventional problems, and is intended to improve the quality of an active ingredient even for a solid drug unstable to moisture or a solid drug which is easily vaporized. It is an object of the present invention to provide a dried drug product and a drug package that can stably retain the drug for a long period of time.

[0005]

In order to achieve the above-mentioned object, a dried product for medicine of the present invention is constituted by enclosing a desiccant in a plastic film bag excellent in moisture permeability and moisture resistance.

Further, the medicine package of the present invention is constituted by enclosing a dry body for medicine together with a solid medicine in a sealed body.

[0007]

Embodiments of the present invention will be described below with reference to the drawings.

First, FIG. 1 is an explanatory sectional view of a dried product for medicine of the present invention. A desiccant 20 is sealed in a plastic film bag 10 which is excellent in moisture permeability and air resistance.

Here, the plastic film may be any one having excellent moisture permeability and air-proofing property.
0g ・ mm / m ²・ 24hr (Measurement method: ASTM F1249, 40 ° C
-90% RH) or more, O ₂ permeability 5.0 ml (STP) ·
^{mm / m 2 · 24hr · atm} ( measurement method: ASTM D3985,23 ℃
-0% RH) and CO ₂ permeability of 12.0 ml (ST
P) · mm / m ² · 24 hr · atm (measurement method: same as O ₂ transmittance) The following is preferably selected as an index.

As such a plastic film, for example, a nylon film, a polyvinyl chloride film, and a polyethylene terephthalate film are preferable in terms of film strength, but a polyacrylonitrile film, a polyvinyl alcohol film, and the like can also be used. Incidentally, the physical properties of these films are as shown in Table 1.

[0011]

[Table 1]

Although these plastic films may be made by using a single film, as shown in FIG. 2, they are made by using a film obtained by laminating two kinds of films 10a and 10b via a urethane adhesive or the like. It is desirable that the bag is obtained because it is superior in strength.

Here, the combination of the laminating is made of any one of a nylon film, a polyvinyl chloride film, and a polyethylene terephthalate film having no heat sealing property and a heat sealing polyacrylonitrile film or polyvinyl alcohol. Combination with a film-making film gives particularly good results, since a film which could not be heat-sealed by itself can be made heat-sealable.

The desiccant 20 used in the present invention can be selected from those which adsorb organic or inorganic gas. Examples thereof include silica alumina gel, silica gel, and silica gel.
Preference is given to disk-shaped or sheet-shaped solid desiccants mainly composed of synthetic or natural zeolites.

FIG. 3 is a sectional view of the medicine package of the present invention. The drying agent 2 enclosed in a plastic film 10 together with a solid medicine 40 such as a tablet is placed in a sealed body 30.
The above-mentioned dried body consisting of 0 is enclosed.

Here, as the solid drug 40, a drug unstable to water or a drug that easily vaporizes is effective, and particularly, (-)-(2)
S, 3aS, 7aS) -tert-butylammonium 1-
[(S) -2-[[(S) -1- (ethoxycarbonyl) butyl] amino] -1-oxopropyl] octahydroindole-2-carboxylate (hereinafter referred to by the general name "perindopril erbumin") The active ingredient can have a remarkable effect on quality stability.

Here, as the sealing body 30, any form and material such as bottles, cans, bags, etc. may be used as long as they have a sealing property.

Next, the present invention will be further described with reference to test examples. Test Example 1 A tablet containing perindopril erbumin as an active ingredient and a disc-shaped desiccant (silica-alumina gel) in the form shown in Table 2 were both enclosed in a glass bottle. H. Of the content of the active ingredient with time,
It was measured by the PLC method. Table 2 shows the results.

[0019]

[Table 2]

[0020]

According to the present invention, the moisture in the solid drug is quickly adsorbed to the desiccant, and the adsorption of the vaporized component to the desiccant is delayed. The quality of the active ingredient can be stably maintained for a long period of time even with a solid drug that is easily vaporized.

[Brief description of the drawings]

FIG. 1 is an explanatory cross-sectional view of a dried product for a drug of the present invention.

FIG. 2 is an explanatory sectional view of a laminate film for bag making.

FIG. 3 is an explanatory sectional view of the medicine package of the present invention.

[Explanation of symbols]

 10: plastic film bag 10a, 10b: plastic film 20: desiccant 30: bottle 40: solid drug

Claims (9)

[Claims] 1. A drug dry body characterized in that a desiccant is sealed in a plastic film bag excellent in moisture permeability and air resistance. 2. A plastic film having a moisture permeability coefficient of 1.0.
g · mm / m^Two・ Over 24 hours, O_Two5.0 mL transmittance (ST
P) mm / m^Two・ 24hr ・ atm or less and CO _TwoTransmittance 1
2.0 ml (STP) mm / m^Two・ 24hr ・ atm or less
The pharmaceutical dry according to claim 1, which is a plastic film.
body. 3. The dry drug product according to claim 1, wherein the plastic film is a nylon film, a polyvinyl chloride film, a polyethylene terephthalate film, a polyacrylonitrile film, or a polyvinyl alcohol film. 4. The plastic film according to claim 1, wherein the plastic film is a laminate film of any one of a nylon film, a polyvinyl chloride film, and a polyethylene terephthalate film and a polyacrylonitrile film or a polyvinyl alcohol film. Dry body for medicine. 5. The dry product for medicine according to claim 1, wherein the desiccant is a desiccant that adsorbs an organic gas or an inorganic gas. 6. The dried product for medicine according to claim 5, wherein the desiccant is a silica-alumina gel, silica gel, or a solid desiccant mainly composed of synthetic or natural zeolite. 7. A sealed body together with a solid drug.
A drug package, wherein the drug product according to any one of the above is enclosed. 8. The solid drug is a drug which is unstable in water and / or a drug which is entirely or partially easily vaporized.
The pharmaceutical package according to the above. 9. The solid drug is (-)-(2S, 3aS, 7).
aS) -Tertiary butyl ammonium 1-[(S) -2-
[[(S) -1- (ethoxycarbonyl) butyl] amino] -1-oxopropyl] octahydroindole-
The drug package according to claim 7 or 8, which is a drug containing 2-carboxylate as an active ingredient.